7 Intriguing Facts about Humira Generics and Biosimilars

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Medically reviewed by, Russell Braun RPH

Have you ever seen the commercials on TV touting Humira? Everyone looks so healthy and happy. You wonder, could that drug make me feel that way too? In contrast did you ever stop to think how expensive it could be?

Humira is a prescription only biologic medication that treats inflammatory conditions. Consequently, it is the top selling drug in the world based on revenue it produces for AbbVie who manufactures the drug.

The Food and Drug Administration (FDA) approved Humira in 2002, since then it has brought in hefty profits due to it being available by brand name only. According to the New York Times the cost of Humira has doubled from $19,000 per year then to over $65,000 per year.

In fact in 2018 it brought in an astounding $20 billion dollars in revenue, making up over 65% of AbbVie’s revenue. Lower cost options in must exist…right? First you need to understand why the drug is so popular.

1. What is Humira?

Humira is a biologic drug that blocks the effects of a substance called TNF alpha. Let’s explain what that means exactly, to help understand why this drug is so expensive.

TNF alpha stands for Tumor Necrosis Factor alpha is a protein involved in the regulation of immune cells. This specific type of protein is called a cytokine because of the actions it exerts in the body. First of all, the immune system detects a problem. As a result, cytokines are produced by immune cells that are involved in the early stages of an immune response. When there is too much TNF alpha or it causes a reaction that is stronger than it should, it leads to inflammation.

Therefore, Humira was created to bind to TNF alpha and blocks it’s effects. Above all this prevents damage of healthy cells which can sometimes be collateral damage in immune system reactions.

2. What is Humira used for?

TNF alpha has been linked to many autoimmune diseases. An autoimmune disease is a condition where the immune system gets confused. Healthy organs and cells in your body are attacked because of this confusion. Normally, the immune system can tell the difference between healthy cells and viruses or bacteria. When there is too much or defective TNF alpha autoimmunity is the result.

Given that Humira binds to and blocks the effects of TNF alpha, it is a candidate for treating autoimmune diseases. Some examples of areas in the body that are affected because of immune attack include:

  • Joints
  • GI tract
  • Skin
  • Spine
  • Eyes

FDA approved uses for Humira

UseBodypart affected
Rheumatoid Arthritis (RA)Joints
Juvenile Idiopathic Arthritis (JIA)Joints
Psoriatic Arthritis (PsA)Joints & Skin
Ankylosing Spondylitis (AS)Spine
Crohn’s Disease (CD)GI Tract & body
Ulcerative Colitis (UC)GI Tract
Plaque Psoriasis (Ps)Skin
Hidradentitis Suppurativa (HS)Skin
Uveitis (UV)Eyes

Inflammation in these body parts cause swelling, pain and damage to the tissues. Furthermore, this leads to decreased range of motion and lowered quality of life.

Humira has become the best selling drug by revenue in the world due to two reasons.

  1. It is approved by the FDA for many uses.
  2. Long term studies have shown significant benefits from taking Humira.

3. Is there a generic for Humira?

Humira was approved by the FDA in 2002. It seems logical that like other blockbuster drugs that Humira might soon lose its patent and become generic. Unfortunately, there are a few reason why that is not the case…. at least for now.

Biologics do not have generics

Most non-biologic medications are referred to as small molecules. This simply means they are not large chemical structures like biologic drugs are. Therefore, they can be produced fairly easily using chemical processes in a lab.

Biologic drugs are produced from living organisms using biotechnology. Organisms are grown for the purpose of harvesting the byproduct they produce, which in this case is the drug Humira. Scientists maximize production of the drug by giving the organisms the right environment and food sources it needs to produce Humira.

Because biologic drugs are made inside of living organism they are proteins, which are large, complex and hard to produce. Even if nearly identical processes are used some variances would still exist between Humira and someone trying to create a generic.

Simply put… a generic will NEVER exist for Humira. Never fear, biosimilars are almost here.

4. Is there a substitute for Humira?

Humira is the brand name of the actual active drug ingredient which is called Adalimumab. As mentioned generics are not possible for Adalimumab, however biosimilars are.

What is a biosimilar?

Biosimilar is the name that was given to a new type of similar drugs, when generics are not possible. Because biologic drugs are all unique the only way to create something like the brand product is to create something biologically similar, hence the name.

The definition of a biosimilar is a biological product that is highly similar to and has no clinically meaningful difference from an existing FDA-approved drug. First of all, “highly similar” means it is almost identical in structure and function. Likewise, “no clinically meaningful difference” means it has the same safety, purity, potency and effectiveness of the brand drug.

What does Interchangeable mean?

When you go pick up a prescription at the pharmacy over 90% of the time there will be a substitution by the pharmacist to using the generic product. In some states it is the law that a pharmacist must use a generic when possible.

However, just because there are biosimilars for biologic drugs like Humira, that does NOT mean they can be switched without requesting approval from your doctor. Unless, they have gone through the steps to get an interchangeable designation.

The FDA also recognizes two types of biosimilar drugs.

  1. Biosimilar – must request permission from the doctor to change from Humira to the biosimilar.
  2. Interchangeable – can be switched to the biosimilar product without asking the doctor.

At this time there are no drugs that have achieved the interchangeable designation.

5. Is there a Biosimilar for Humira?

To date, the FDA has approved 5 biosimilars to Adalimumab. However, the slew of patents that AbbVie has created has prevented the biosimilars from being available for sale in the U.S. Even though they can’t be sold in the U.S. yet the manufacturers are lining up to take profits away from AbbVie.

Patents, patents, patents

The actual patent for Humira expired in 2016. Consequently, AbbVie looked for ways they could prevent competitors from making biosimilar versions of Humira. The answer was to put the legal team to work, so creating new patents became a full time job.

While they could not simply do another patent on the drug itself, they found other ways. For that reason, additional patents were focused on the processes they used to manufacture Humira. So many were created they have been referred to as a “patent thicket”. Imagine a thicket that is dense and hard for competitors to break through and create a similar drug.

The manufacturers of these biosimilars could sell the product however, they could be sued for doing so. Court cases have come up due to this and instead of 2034 being the date when a biosimilar versions can be sold here, the date has been reigned in to January of 2023.

Currently approved Biosimilars

The table below lists five biosimilars that will be for sale in 2023. These drugs have undergone studies that show they are equally safe and effective as Humira.

Humira comes as an injection pen. Some of the biosimilar products may be different in there packaging or how they injection works, because of all the patents. Furthermore, all Humira biosimilars to date are subcutaneous injections given under the skin.

Approval yearDrug nameGeneric designation

Biosimilars are different than generic drugs in a few more ways. Most generic drugs just take the name of the main chemical ingredient, for Humira it would be Adalimumab. However, due to the fact that each drug is not identical, the FDA requires the generic name plus a four letter suffix at the end. This makes identifying the correct product easier.

Once a manufacturer creates a biosimilar they give it a name, similar to a brand name that is easier to say and remember. They want to make sure doctors remember to use their product and not a competitors.

6. Lower prices are coming

As you can see there will be competition coming for Humira in 2023. This will significantly lower the price of Humira, which is currently $5490 per month according to GoodRx

In Europe where they have many more biosimilars available than the United States, prices have gone down significantly. As a result competitors started selling biosimilars as soon as the drug patent expired, back in 2016.

What can you do between now and 2023 to lower your prescription cost? Read 11 money saving tips you should know before using the Humira co-pay card for a step by step explanation.

7. Is Enbrel a biosimilar?

Finding lower cost drug options, often called therapeutic alternatives, is a best practice for saving on medication. Therapeutic alternatives are drugs that have chemically different contents but work in a similar way to treat a condition.

Enbrel is a drug that is also a TNF-alpha inhibitor like Humira. Therefore, it is not a biosimilar option for Humira. Although a biosimilar to Enbrel called Erelzi (etanercept-szzs) is available and does treat some of the same conditions as Humira. Once again, patents have stopped Erelzi from being sold in the U.S., but it is available in Europe.

Remicade was the first TNF-alpha blocker available and it also has a biosimilar. Inflectra (infliximab-dyyb) is the biosimilar to Remicade. In contrast to Humira, this is not a shot taken under the skin. Rather you must go into a hospital or outpatient clinic for an intravenous infusion. Therefore, there may be extra costs associated with going to the infusion facility.

Click here to get Dr. Jason Reed’s exclusive list of medication questions you MUST ask your doctor, for FREE!

Share your story!

Have you used Humira? Likewise, tell us if you have tried any biosimilar product. How well did either work for you? Please chime in below with your comments and thoughts below.

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